A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
Not applicable · Testing For a bipsies and rectal administration · 1 site · Catholic University of the Sacred Heart
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing For a bipsies (a diagnostic test) and rectal administration (a dietary supplement) as a way to diagnose or measure disease. Condition(s) listed: Ulcerative Colitis and Crohn Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- Men or women 18 to 80 years of age at the time of consent
- Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening
- Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase
Plus 2 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2025-05-14.
- Main results expected around 2026-09-14 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing (1 year)
In the researchers’ words
Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Crohn Disease |
| Lead sponsor | Catholic University of the Sacred Heart |
| Enrollment | 20 (estimated) |
| Start date | 2025-05-14 |
| Primary completion (est.) | 2026-09-14 |
| First posted | 2026-07-24 |
| Last updated | 2026-07-27 |
| Official title | A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study |
| ClinicalTrials.gov ID | NCT07724990 |
Interventions
- For a bipsies (Diagnostic Test)
For the collection of a few additional biopsies - rectal administration (Dietary Supplement)
rectal administration of a specific probiotic
Full eligibility criteria (from the record)
Inclusion Criteria: * Men or women 18 to 80 years of age at the time of consent * Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening * Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase * Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening * Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments. Exclusion Criteria: * concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded. * Intolerance to topical therapy (enemas) * Allergy to A. muciniphila or any other component of the IP * Crohn's disease or inflammatory bowel disease unclassified (IBD-U) * Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period. * Subject who received topical therapy (i.e., enema or suppository of aminosalicylates / corticosteroids) within 14 days prior to Screening or during the Screening period. * Subject who received fecal microbial transplantation within 3 months prior to Baseline. * Subjects with the following chronic or active infections: * Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study * Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice, * Are infected with human immunodeficiency virus (HIV), * Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study. * Pregnancy and breastfeeding
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli, IRCCS | Roma, RM | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.